SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8781 results)

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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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QuickProfile™ Drugs of Abuse Panel 4 Test - M90107RD7063280

Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI / OXY
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-28
In Commercial Distribution

  • M90107RD7063280 ()
  • M90107RD7063281 ()

  • Length: 75 Millimeter
07RD7063-28

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 4 Test - M90107RD7063030

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / MTD / OPI
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-03
In Commercial Distribution

  • M90107RD7063031 ()
  • M90107RD7063030 ()

  • Length: 75 Millimeter
07RD7063-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 4 Test - M90107RD7063020

Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-02
In Commercial Distribution

  • M90107RD7063021 ()
  • M90107RD7063020 ()

  • Length: 75 Millimeter
07RD7063-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 4 Test - M90107RD7063010

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7063-01
In Commercial Distribution

  • M90107RD7063011 ()
  • M90107RD7063010 ()

  • Length: 75 Millimeter
07RD7063-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 3 Test - M90107RD7062040

Immunoassay for the detection of the following drug substance(s) in human urine: COC / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-04
In Commercial Distribution

  • M90107RD7062041 ()
  • M90107RD7062040 ()

  • Length: 75 Millimeter
07RD7062-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 3 Test - M90107RD7062020

Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7062-02
In Commercial Distribution

  • M90107RD7062021 ()
  • M90107RD7062020 ()

  • Length: 75 Millimeter
07RD7062-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD706104A0

Immunoassay for the detection of the following drug substance(s) in human urine: BZD / OPI-2000
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-04A
In Commercial Distribution

  • M90107RD706104A1 ()
  • M90107RD706104A0 ()

  • Length: 75 Millimeter
07RD7061-04A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD7061030

Immunoassay for the detection of the following drug substance(s) in human urine: MAMP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-03
In Commercial Distribution

  • M90107RD7061031 ()
  • M90107RD7061030 ()

  • Length: 75 Millimeter
07RD7061-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD706102A0

Immunoassay for the detection of the following drug substance(s) in human urine: M-AMP / OPI-2000
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-02A
In Commercial Distribution

  • M90107RD706102A1 ()
  • M90107RD706102A0 ()

  • Length: 75 Millimeter
07RD7061-02A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

QuickProfile™ Drugs of Abuse Panel 2 Test - M90107RD7061010

Immunoassay for the detection of the following drug substance(s) in human urine: COC / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7061-01
In Commercial Distribution

  • M90107RD7061011 ()
  • M90107RD7061010 ()

  • Length: 75 Millimeter
07RD7061-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini - 00815381020765

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424589
In Commercial Distribution

  • 00815381020765 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

BioFire® Blood Culture Identification 2 (BCID2) Panel - 00815381020345

IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0148
In Commercial Distribution

  • 00815381020345 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

BioFire® Blood Culture Identification 2 (BCID2) Panel - 00815381020338

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0147
In Commercial Distribution

  • 00815381020338 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry

BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests - 00815381020239

IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423883
In Commercial Distribution

  • 00815381020239 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

CLA® Allergen-Specific IgE Assay - Moderate Food Panel - 00813382010174

KIT, Moderate Food
Minaris Medical America, Inc.
84518
In Commercial Distribution

  • 00813382010174 ()
84518

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

CLA® Allergen-Specific IgE Assay - Western Inhalant Panel - 00813382010167

KIT, Western Inhalant
Minaris Medical America, Inc.
84511
Not in Commercial Distribution

  • 00813382010167 ()
84511

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel - 00813382010150

KIT, Southwestern Inhalant
Minaris Medical America, Inc.
84509
Not in Commercial Distribution

  • 00813382010150 ()
84509

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel - 00813382010143

KIT, Southeastern Inhalant
Minaris Medical America, Inc.
84507
In Commercial Distribution

  • 00813382010143 ()
84507

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel - 00813382010136

KIT, Pediatric Comprehensive
Minaris Medical America, Inc.
84506
Not in Commercial Distribution

  • 00813382010136 ()
84506

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay

CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel - 00813382010129

KIT, Northwestern Inhalant
Minaris Medical America, Inc.
84505
Not in Commercial Distribution

  • 00813382010129 ()
84505

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay
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